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IRCT20220726055558N1 IRCT 2022-10-19 Yazd University of Medical Sciences Cornelian cherry fruit extract in patients with non-alcoholic fatty liver disease. Effect of cornelian cherry fruit extract on the inflammatory (IL-6) and oxidative (GPx) factors in patients with non-alcoholic fatty liver disease. 2022-11-29 anticipated 50 Complete https://irct.ir/trial/64967 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: People will be randomly assigned to intervention group with standardized blueberry fruit extract based on total anthocyanin or placebo group. Random allocation table created by Random allocation software and computer is used for random allocation of people in groups. Random allocation is also done in the form of stratified randomization based on age and gender, Blinding description: After preparing the standardized cranberry fruit extract based on total anthocyanin and placebo, the products were packaged in similar colored bottles in terms of color, shape and size and named A and B by a person outside the study who is not aware of the details of the study. , are labeled, and thus participants and researchers will not know about the nature of the products in the bottles. The person measuring the indicators of the laboratory is not aware of receiving or not receiving the drug or placebo. 3 Condition 1: People with non-alcoholic fatty liver with grades 1, 2, 3. Condition 2: People with non-alcoholic fatty liver with grades 1, 2, 3. Intervention 1: Intervention group:Intervention group: 20 cc (twice a day in the morning and at night for 12 weeks) of blueberry fruit extract (cornus mas L.) standardized on the basis of total anthocyanin (320 mg of anthocyanin), from the edible part of the blueberry fruit (cornus mas) L.) and is prepared in the pharmacology department of the Faculty of Pharmacy, Shahid Sadougi University of Medical Sciences, Yazd. Intervention 2: : Control group: In the placebo group, people receive the same amount of extract from the placebo product as in the extract group. It will be 20 cc (twice a day in the morning and at night for 12 weeks). And it is prepared in the pharmacology department of the Faculty of Pharmacy, Shahid Sadougi University of Medical Sciences, Yazd. Yes - There is a plan to make this available What will be shared: No - There is not a plan to make this available When: No - There is not a plan to make this available To whom: No - There is not a plan to make this available Conditions: No - There is not a plan to make this available Where to obtain: No - There is not a plan to make this available How to obtain: No - There is not a plan to make this available Comments:
public Mr. Dr. Hassan Mozafari Khosravi
Yazd - Alam Square - Shahid Sadougi University of Medical Sciences and Health Services Campus - Faculty of Health
Yazd Iran (Islamic Republic of) 891517316 009838209100 ravabet.odb@ssu.ac.ir Yazd University of Medical Sciences scientific Mr. Dr. Hassan Mozafari Khosravi
Yazd - Alam Square - Shahid Sadougi University of Medical Sciences and Health Services Campus - Faculty of Health
Yazd Iran (Islamic Republic of) 8915173160 +98 35 3820 9100 ravabet.odb@ssu.ac.ir Yazd University of Medical Sciences Iran (Islamic Republic of) ALT levels more than U/L 30 in men a age 25-65 years diagnosis of NAFLD and patients with grade 1, 2 and 3 fatty liver willingness and consent of the person to participate in the study Being a native of Yazd ALT levels greater than U/L 19 in women 25 years 65 years Both History of diseases including liver cirrhosis, viral hepatitis, cardiovascular diseases History of taking drugs, including corticosteroids, or any drug affecting blood sugar any drug or supplement affecting the liver within 1 month before the study history of following a specific diet within 1 month before the study breastfeeding and pregnancy alcohol consumption K75.81 K76.0 Nonalcoholic steatohepatitis (NASH) Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group:Intervention group: 20 cc (twice a day in the morning and at night for 12 weeks) of blueberry fruit extract (cornus mas L.) standardized on the basis of total anthocyanin (320 mg of anthocyanin), from the edible part of the blueberry fruit (cornus mas) L.) and is prepared in the pharmacology department of the Faculty of Pharmacy, Shahid Sadougi University of Medical Sciences, Yazd. : Control group: In the placebo group, people receive the same amount of extract from the placebo product as in the extract group. It will be 20 cc (twice a day in the morning and at night for 12 weeks). And it is prepared in the pharmacology department of the Faculty of Pharmacy, Shahid Sadougi University of Medical Sciences, Yazd. Interleukin 6. Timepoint: Before the intervention and the end of the intervention after 12 weeks. Method of measurement: Measurement of plasma glutathione peroxidase by ELISA method. Glutathione peroxidase. Timepoint: Before the intervention and the end of the intervention after 12 weeks. Method of measurement: Measurement of plasma glutathione peroxidase by ELISA method. Weight. Timepoint: Before the intervention and the end of the intervention after 12 weeks. Method of measurement: SECA scales. Waist circumference. Timepoint: Before the intervention and the end of the intervention after 12 weeks. Method of measurement: Inflexible meter. Hip circumference. Timepoint: Before the intervention and the end of the intervention after 12 weeks. Method of measurement: Inflexible meter. Yazd University of Medical Sciences Approved 2022-04-24 Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd Yazd- Shahid Dr. Bahnar Square- Central Organization of Shahid Sadoughi University of Medical Sciences and Healthcare Services, Yazd Shahid Sadoughi University of Medicine and Healthcare Services, Yazd- yazd Yazd Iran (Islamic Republic of)